Mayo Clinic IBD Biobank

Inflammatory Bowel Diseases Clinical Trial

Official title:

Mayo Clinic IBD Biobank

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03756649
• Other study ID #: 18-007941
• Status: Enrolling by invitation
• Start date: November 1, 2018
• Est. completion date: December 2065

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Researchers are collecting and storing blood, stool, and urine samples and medical information to better understand Inflammatory Bowel Disease (IBD) to improve disease outcome.

Description:

Subjects will be sent a letter detailing the proposed biobank and soliciting enrollment. Following the informed consent process, subjects will provide a blood sample (50 ml), urine sample (50 ml), and stool. The blood and urine samples will either be collected at the one of the Mayo Clinic outpatient laboratories or by a mail-out kit. Subjects will be asked to complete a questionnaire and 24-hour food recall questionnaire (completed online).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 2065
• Est. primary completion date: December 2065
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with inflammatory bowel disease (IBD) who are between the ages of 18 and 85 at time of study enrollment.

• The diagnosis of IBD will be based on the standard IBD criteria including biochemical and colonoscopy screening.

• Women with inflammatory bowel disease of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.

• Patients between the ages of 18 and 85 without history of IBD or colon cancer.

Exclusion Criteria:

• Patients with known liver disease.

• Patients unable to provide informed consent.

• Prisoners and institutionalized individuals.

• Patients with a history of colorectal cancer.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases

Intervention

Procedure:
• Blood Draw
50 ml will be collected
• Urine Collection
50 ml will be collected
• Stool Collection
Three 25 ml tubes will be collected

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Participants	Total number of participants in the study	50 years
Secondary	Urine Collection	Total number of urine samples collected	50 years
Secondary	Blood Collection	Total number of blood samples collected	50 years
Secondary	Stool Collection	Total number of stool samples collected	50 years